An observational study in Axial Spondyloarthritis and Fibromyalgia, sponsored by Association de Recherche Clinique en Rhumatologie. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-19.
Sponsored by Association de Recherche Clinique en Rhumatologie · Observational
This is a prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). The objective of recruitment is 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker.
The main objective of the study is to evaluate the impact of a concomitant fibromyalgia on the anti-TNF treatment effect in axial Spondyloarthritis in both anti-TNF naïve and pre-exposed patients.
Background: Diagnosis of SpA in the absence of objective signs of inflammation or structural damage can be challenging, and especially difficult to differentiate from Fibromyalgia. Furthermore, such patients can easily be classified as active and refractory to NSAIDs, and inappropriately receive TNF alpha blockers.
Objective: Primary objective: To evaluate the impact of fibromyalgia in the TNF alpha treatment effect in axial Spondyloarthritis in both anti-TNF naïve and - experienced patients.
Methods: Design: Prospective observational national (France) study with 2 visits 3 months apart (baseline and 12 weeks after TNF alpha blockers initiation). Patients: 500 SpA patients (diagnosis according to their treating rheumatologist) initiating a TNF alpha blocker. Data collection: items permitting the calculation of the ASAS criteria, the FIRST questionnaire (Fibromyalgia Rapid Screen Test), patients and disease characteristics, disease activity and severity items, and the domain leading the doctor's decision for initiating the TNF alpha blocker (CRP/Imaging/Symptoms) will be collected at baseline. Effectiveness measures (e.g. BASDAI and patient's global) and the doctor's decision to continue/discontinue the TNF alpha blocker will be collected during the second visit. Statistical analysis: for the main objective, evaluation of the predictive factors of a TNF alpha response in real life, and the impact of Fibromyalgia in such response (e.g. logistic regression to estimate BASDAI reduction of 50%). For the secondary objectives: evaluation of the relative attributable risks of the doctor's domains leading the TNF alpha blocker initiation (Imaging/CRP/Symptoms) in order to explain the anti-TNF therapy response; evaluation of the concordance existing between the current recommendations and the daily practice.
Expected results: A positive finding might results into a change in the way of managing patients (e.g. carefully checking for the co-existence of fibromyalgia before confirming a spondyloarthritis diagnosis, an active disease and also before initiating a specific therapy such as biologics.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 527 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Association de Recherche Clinique en Rhumatologie is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from SpA based on the opinion of the treating rheumatologist initiating a TNF alpha blocker.
Exclusion Criteria:
Other: Follow-up after 12 weeks after TNF alpha blockers initiation
Other: Follow-up after 12 weeks after TNF alpha blockers initiation
To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers
The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
Time frame: At 12 weeks after TNF alpha blockers initiation
The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy
Time frame: At 12 weeks after TNF alpha blockers initiation
Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)
Time frame: At 12 weeks after TNF alpha blockers initiation
Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.
Time frame: At baseline and at 12 weeks after TNF alpha blockers initiation
| Milestone | Fibromyalgia Patients | Not Fibromyalgia Patients |
|---|---|---|
| Started | 192 | 316 |
| Completed | 192 | 316 |
| Not completed | 0 | 0 |
The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.
| participants | Fibromyalgia Patients | Not Fibromyalgia Patients |
|---|---|---|
| To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers | 87 | 171 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibromyalgia Patients | — | 0/202 (0%) | 0/202 (0%) |
| Not Fibromyalgia Patients | — | 0/324 (0%) | 0/324 (0%) |
| Age, Categorical(Participants) | Fibromyalgia Patients | Not Fibromyalgia Patients | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 202 | 324 | 526 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Fibromyalgia Patients | Not Fibromyalgia Patients | Total |
|---|---|---|---|
| Mean | 41.6 ± 10.7 | 41.1 ± 12.1 | 41.3 ± 11.6 |
| Sex: Female, Male(Participants) | Fibromyalgia Patients | Not Fibromyalgia Patients | Total |
|---|---|---|---|
| Female | 111 | 134 | 245 |
| Male | 91 | 190 | 281 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Association de Recherche Clinique en Rhumatologie